Hepatitis C Treatment in Underserved Populations

Not Applicable

• Conditions: Chronic Hepatitis C; Illicit Drug Use
• Interventions: Other: Collaborative, multidisciplinary, integrated care

• Registration Number: NCT01717560
• Lead Sponsor: Brian Edlin

Brief Summary

The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.

Detailed Description

This study examines the feasibility of integrated treatment for hepatitis C in active IDUs using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. The Weill Cornell Medical College Center for the Study of Hepatitis C collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2008-04-29
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-25
• Last Update Submitted: 2012-10-25
• Study First Posted: 2012-10-30
• Last Update Posted: 2012-10-30
• Primary Completion: 2012-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age 18 years or older
• Used heroin, cocaine, or injected other drugs for at least 1 year
• Have used heroin, cocaine and/or methamphetamine within the last 30 days
• Test positive for HCV antibody
• Are interested in being evaluated for HCV treatment

Exclusion Criteria

• Persons who are obviously intoxicated, incoherent or otherwise unable to give informed consent are excluded from participation. Such persons may participate in the study if they return at a later date and are capable of providing informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Collaborative multidisciplinary integrated care	Collaborative, multidisciplinary, integrated care	Collaborative, multidisciplinary, integrated care for hepatitis C

Primary Outcome Measures

Name	Time	Method
Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.	24 weeks after completion of antiviral treatment	SVR is measured 24 weeks after completion of antiviral treatment

Secondary Outcome Measures

Name	Time	Method
initiation of antiviral therapy	Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases.
completion of medical and psychiatric evaluation for antiviral therapy	Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases.
adherence to antiviral therapy	Weekly up to 48 weeks	Adherence is measured weekly during the duration of prescribed antiviral therapy. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient's characteristics, the regimen, and the response to therapy.)
completion of antiviral therapy	Completion is recorded at the time prescribed antiviral therapy is discontinued, whether that happens when the prescribed duration of therapy is complete or before. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient.)
levels of alcohol and illicit drug use	Weekly up to 96 weeks	Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up
entry into treatment for substance use	Monthly up to 24 months	Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
entry into treatment for another unaddressed medical or psychiatric condition	Monthly up to 24 months	Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
neuropsychiatric side effects, including depression and hostility/irritability	Monthly up to 72 weeks	Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter
treatment-limiting systemic, hematologic, or other side effects	Weekly up to 72 weeks	Measured weekly during prescribed course of antiviral therapy and then monthly or quarterly thereafter (TSH, for example, is measured every 3 months during and after treatment)
other adverse events or adverse effects	Monthly up to 72 weeks	Measured monthly during prescribed course of antiviral therapy or as patients bring adverse events or effects to attention of physicians or study staff
reinfection	Quarterly up to 10 years	Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy.

Trial Locations

Locations (1)

Center for the Study of Hepatitis C, Weill Medical College, Cornell University; 🇺🇸 New York, New York, United States